Medical Safety Dir
Hace 2 días
Madrid, España
IQVIA
Jornada completa
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Experteer Overview As Medical Safety Director, you lead pharmacovigilance activities across trials and safety projects, guided by management oversight. You provide global project leadership for multi-advisor efforts and mentor junior staff. You oversee medical reviews of safety data, drive regulatory document content, and represent safety findings in client meetings. You ensure on-time delivery of safety deliverables and maintain up-to-date awareness of regulatory developments. This role combines medical expertise with strategic safety leadership in a dynamic, hybrid work environment.
Compensaciones / Beneficios
- Perform medical review of trial-related AEs and ADRs, including causality, seriousness, and data verification
- Draft and review AOSEs for expedited cases per regulatory requirements
- Advise pharmacovigilance case processing teams as an internal consultant
- Provide aggregate safety data reviews to monitor product safety profile
- Review and code AEs, Past medical history, Concomitant medications for data accuracy
- Present safety findings in client meetings
- Review and edit safety reports (IND Annual Reports, EU PSPs, US PSURs, etc.)
- Oversee Development Risk Management Plans and EU/US risk management strategies
- Provide medical oversight for label development and changes
- Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings
- Contribute to Integrated Safety Summary or CTD safety sections
- Review and sign off on Project Safety Plan and Medical Monitoring Plan
- Medical review of protocols, IDB, and CRFs for safety content
- Act as Global Safety Physician/Assistant/Back-up; lead medical safety projects
- Lead training, delivery, communication, and quality control for projects
- Ensure safety deliverables meet regulatory or contracted timelines
- Provide medical escalation support for safety projects and EU pharmacovigilance roles
- Provide 24-hour medical support on assigned projects
- Keep abreast of medical-safety-regulatory developments
- Participate in RFP reviews, budgeting, and bid defenses for medical safety services
- Attend client meetings to promote medical safety servicesResponsabilidades
- Medical degree (MD) from an accredited medical school
- Three years of clinical practice plus four years in pharmaceutical or related industry, or equivalent
- Knowledge of relevant regulations and guidelines for clinical research, pharmacovigilance, and GCP
- Understanding of clinical trials and pharmaceutical research processes
- Ability to set priorities, meet deadlines, and manage objectives
- Consultation and advisory skills across multiple assignments with initiative and flexibility
- Strong relationship-building with colleagues, managers, and clients
- Valid medical license or equivalent in the residing country/regionRequisitos principales
- hybrid work model
- collaborative culture
- opportunities across IT, data, AI, finance, HR
- career development and mentorship
Compensaciones / Beneficios
- Perform medical review of trial-related AEs and ADRs, including causality, seriousness, and data verification
- Draft and review AOSEs for expedited cases per regulatory requirements
- Advise pharmacovigilance case processing teams as an internal consultant
- Provide aggregate safety data reviews to monitor product safety profile
- Review and code AEs, Past medical history, Concomitant medications for data accuracy
- Present safety findings in client meetings
- Review and edit safety reports (IND Annual Reports, EU PSPs, US PSURs, etc.)
- Oversee Development Risk Management Plans and EU/US risk management strategies
- Provide medical oversight for label development and changes
- Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings
- Contribute to Integrated Safety Summary or CTD safety sections
- Review and sign off on Project Safety Plan and Medical Monitoring Plan
- Medical review of protocols, IDB, and CRFs for safety content
- Act as Global Safety Physician/Assistant/Back-up; lead medical safety projects
- Lead training, delivery, communication, and quality control for projects
- Ensure safety deliverables meet regulatory or contracted timelines
- Provide medical escalation support for safety projects and EU pharmacovigilance roles
- Provide 24-hour medical support on assigned projects
- Keep abreast of medical-safety-regulatory developments
- Participate in RFP reviews, budgeting, and bid defenses for medical safety services
- Attend client meetings to promote medical safety servicesResponsabilidades
- Medical degree (MD) from an accredited medical school
- Three years of clinical practice plus four years in pharmaceutical or related industry, or equivalent
- Knowledge of relevant regulations and guidelines for clinical research, pharmacovigilance, and GCP
- Understanding of clinical trials and pharmaceutical research processes
- Ability to set priorities, meet deadlines, and manage objectives
- Consultation and advisory skills across multiple assignments with initiative and flexibility
- Strong relationship-building with colleagues, managers, and clients
- Valid medical license or equivalent in the residing country/regionRequisitos principales
- hybrid work model
- collaborative culture
- opportunities across IT, data, AI, finance, HR
- career development and mentorship